PMA
P240031: Neuspera Sacral Neuromodulation System
FDA PMA · Stimulator, electrical, implantable, for incontinence · Neuspera Medical, Inc.
Key facts
| PMA number | P240031 |
|---|---|
| Trade name | Neuspera Sacral Neuromodulation System |
| Generic name | Stimulator, electrical, implantable, for incontinence |
| Applicant | Neuspera Medical, Inc. |
| Owner/operator | Neuspera Medical, Inc. |
| Product code | EZW |
| Approval date | Jun 17, 2025 |
| Docket number | 25M-1810 |
| Notice date | Jun 20, 2025 |
| Establishment registration | 3014845032 |
| FEI number | 3014845032 |
At a glance
- 1–9 Supplements
- Aug 21, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: